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CRSPA: CM4620 for Pancreatitis After Asparaginase

About this study

Some people with acute lymphoblastic leukemia or lymphoma receive a medicine called asparaginase. This medicine helps treat cancer. Sometimes, asparaginase can cause a painful problem called pancreatitis. The pancreas is an organ behind the stomach that helps digest food and control blood sugar. Pancreatitis happens when the pancreas becomes swollen and irritated. This can cause belly pain, nausea, vomiting, fever, and a fast heartbeat. In severe cases, pancreatitis can be life threatening.

When pancreatitis happens, doctors may need to stop or change the cancer treatment. Right now, there are not many ways to prevent this problem. Current treatments for pancreatitis only help with the symptoms. They do not fix the cause.

This study tests a new experimental medicine called CM4620. Researchers want to see if CM4620 can make pancreatitis less severe. They also want to find out if CM4620 is safe and what dose works best for children and young adults.

In the study, patients get CM4620 through a vein using an IV for 4 days. Treatment starts soon after pancreatitis begins. The plan is to follow the patients for several weeks and up to about 4 months to watch for side effects, safety, how much drug the body handles, and signs that it helps.

This research may help future patients have fewer severe side effects from cancer treatment. It could also teach doctors more about how to protect the pancreas during therapy. 

Eligibility overview

  • Up to 21 years old
  • Has acute lymphoblastic leukemia/ lymphoma
  • Has acute pancreatitis that started within the past 36 hours after receiving asparaginase treatment within the last few weeks
  • Able to get medicine through an IV (a vein)  

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

CRSPA: Phase I/II Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase

Study goal:

To find out if the experimental medicine CM4620 is safe and can help treat pancreatitis caused by asparaginase in children and young adults with leukemia or lymphoma

Diagnosis:

Acute lymphoblastic leukemia, Lymphoma

Age:

Up to 21 years old

Clinical trial categories:

Lymphoma Acute Lymphoblastic Leukemia (ALL)

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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